Weatherhead JPTOS 2015

26
Investigating Inherency: Inception to AIA
Robin A. Weatherhead, Ph.D.
Abstract
The doctrine of inherent anticipation has a long and convoluted history which has
evolved within the American court system from the late 1800s through present day,
with the advent of the American Invents Act (AIA). The doctrine is typically used to
invalidate a claim for lacking novelty over an inherent undisclosed feature present in
the prior art. More recently, the Federal Circuit has clariﬁed that this doctrine may
also be applied to invalidate a claim as obvious. This paper examines the evolution
of inherency, and further examines how inherency may be properly applied within
the conﬁnes of the obviousness inquiry. This paper concludes with a discussion of
whether the doctrine of inherent anticipation will have a place under the new AIA
regime.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
I. Evolution of the Doctrine of Inherent Anticipation 28
A. Distinguishing Accidental Anticipation from Inherent Anticipation . . . 28
B. Should Recognition be Required in the Inherency Analysis? . . . . . . . 31
C. Schering v. Geneva (2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
II. After Schering 36
A. The Schering Dissenters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
B. SmithKline Beecham Corp. v. Apotex Corp. (2005) . . . . . . . . . . . . . . . 37
C. In re Omeprazole Patent Litigation (2008) . . . . . . . . . . . . . . . . . . . 40
III.Inherent Anticipation Applied to Obviousness 44
A. In re Dillon (1990) and the Concept of “Reverse Inherency” . . . . . . . . 45
B. Recent Application of Inherency to Obviousness: 2011 to present . . . . 47
1. In re Kao (2011) and Par Pharmaceutical (2014) . . . . . . . . . . . . 47
2. Allergan v. Sandoz (2013) . . . . . . . . . . . . . . . . . . . . . . . 50
C. Inherent Obviousness Deconstructed . . . . . . . . . . . . . . . . . . . . 54
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Journal of the Patent & Trademark Office Society
jptos.org

VOL 97, NO 1 Weatherhead 27
Introduction
The doctrine of inherent anticipation has been characterized as “perhaps the most elu-
sive doctrine in all of patent law,”1
a characterization which stems, in part, from its in-
consistent application prior to the landmark Schering v. Geneva2
decision. Although in-
herency manifests itself across a broad spectrum of patent-related issues, the doctrine is
best known and most often applied within the context of anticipation.3
Under 35 U.S.C.
§ 102, a claim is anticipated— and thus unpatentable— only if each and every element
as set forth in the claim is found in a single prior art reference.4
Anticipation does not
require the actual creation or reduction to practice of the prior art subject matter, but re-
quires only an enabling disclosure that delivers the claimed invention to the public prior
to its critical date.5
Of course, establishing anticipation is straightforward if the prior art reference ex-
pressly discloses each and every element of the claim.6
Anticipation becomes more diffi-
cult to establish, however, when the prior art reference is silent with regard to a particu-
lar claimed element, but where such element simply inheres in the disclosure.7
Extrinsic
evidence— such as data, additional references, and/or expert testimony— may be used,
for example, to show that the element not expressly disclosed in the primary prior art
reference is inherently disclosed.8
The mere fact that the primary prior art reference may
disparage, teach away, or even expressly exclude the inherent element is not at all rele-
vant to the inherency inquiry under 35 U.S.C. § 102.9
The difficulties concerning inherent anticipation that American courts have grappled
with over time, but which now appear resolved, are, first, whether an element is inher-
ently disclosed if it is “accidentally” and “unwittingly” produced while in the pursuit
of other and different results, and, secondly, whether an element is inherent if there was
no knowledge or appreciation of its existence prior to the critical date of the claimed
invention.10
Confusion still remains, however, as to whether the doctrine of inherent
anticipation may be properly applied under 35 U.S.C. §103, the obviousness inquiry.11
This paper is divided into three parts. Part 1 describes the doctrine of inherent an-
ticipation from its inception up to the Schering decision within the realm of 35 U.S.C.
§ 102, the novelty regime. Part 2 examines the views of the Schering dissenters within
1
Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371, 373 (2005).
2
Schering Corp. v. Geneva Pharmaceuticals, Inc. 339 F.3d 1373 (Fed. Cir. 2003).
3
See, e.g., MPEP (9th
ed., Mar. 2014) § 2112.
4
ed., Mar. 2014) § 2131; Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987).
5
The critical date, otherwise known as the date of the inventor’s proof of invention, is the specified date of old (pre-AIA)
35 U.S.C. §102(a). Under the new (AIA) 35 U.S.C. §102(a)(1), the specified date is now the effective filing date of the patent
application.
6
ed., Mar. 2014) § 2131.
7
ed., Mar. 2014) § 2112.
8
ed., Mar. 2014) § 2131.01; See also Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.
Cir. 1991).
9
ed., Mar. 2014) § 2131.05.
10
See supra note 5. The critical date, otherwise known as the date of the inventor’s proof of invention, is the specified date of
old (pre-AIA) 35 U.S.C. §102(a). Under the new (AIA) 35 U.S.C. §102(a)(1), the specified date is now the effective filing date of
the patent application.
11
See, e.g., Robert Shulman, David Kelly & Alexander Spiegler, “Recent Trends in Patent Practice: The Federal Cir-
cuit’s Treatment of Pharmaceuticals,” Life Sciences Law & Industry 1(12): 442-448 (2007); Eric Dittmann & Jamie
Lucia, IP: Is the Federal Circuit trying to merge inherency and obviousness?, Inside Counsel Mag. (Aug. 27, 2013),
http://www.insidecounsel.com/2013/08/27/ip-is-the-federal-circuit-trying-to-merge-inherenc.

28 Investigating Inherency JPTOS
the context of two subsequent cases, SmithKline Beecham Corp. v. Apotex Corp12
decided
in 2005, and In re Omeprazole Patent Litigation13
decided in 2008, following and uphold-
ing the Schering decision. Part 3 explores whether the doctrine is, as some practitioners
have put it, impermissibly “merging” within the 35 U.S.C. § 103 obviousness inquiry.14
This paper concludes with a discussion of whether the doctrine of inherency will exist
post-American Invents Act (AIA).15
I. Evolution of the Doctrine of Inherent Anticipation
A. Distinguishing Accidental Anticipation from Inherent Anticipation
The 1880 Supreme Court case Tilghman v. Proctor16
began the American courts’ captiva-
tion with the concept of inherency. In Tilghman, the inventor discovered that by pumping
a mixture of neutral fat and water through a coil of pipe at high temperature and pres-
sure followed by cooling, glycerine separated as a solid from the solution containing
fatty acid by-products.17
Tilghman sought and obtained U.S. Patent 11,766 reciting a sin-
gle claim broadly covering his invention: “I claim . . . the manufacturing of fat acids and
glycerine from fatty bodies by the action of water at a high temperature and pressure.”18
Tilghman later brought suit against William Proctor, James Gamble, and George Proctor,
co-partners of Proctor & Gamble, for infringement of the ’766 patent.19
Prior to discussing the merits of infringement, the Supreme Court addressed various
prior art processes that allegedly also effected decomposition of fat into fatty acids and
glycerine.20
One such prior art process was the lubrication of a cylinder of a steam engine
with tallow which, via the combined action of steam and high temperature and pressure
on the tallow coating, likely produced the claimed products in the scum on the water
issuing from the ejection pipe.21
The Court, however, did not regard this process as
inherent, and thus novelty destroying, since the formation of the fatty acids and glycerine
was “accidental” and “never fully understood.”22
The oft-quoted language used by the
Court, “[i]f the acids were accidentally and unwittingly produced, whilst the operators
were in pursuit of other and different results, without exciting attention and without its
even being known what was done or how it had been done, it would be absurd to say
that this was an anticipation of Tilghman’s discovery,”23
was later boiled down to a more
simplistic slogan: “accidental results not intended and not appreciated, do not constitute
anticipation.”24
12
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005).
13
In re Omeprazole Patent Litigation, 536 F.3d 1361, 1365 (2008).
14
See Dittmann, supra note 11.
15
Leahy-Smith America Invents Act, Pub. L. Bi, 112-29, 125 Stat. 284 (2011).
16
102 U.S. 707 (1880).
17
Id. at 709.
18
Id. (hereinafter “the ’766 patent”).
19
Id. at 707.
20
Id. at 708-712.
21
Id. at 711.
22
Id.
23
Id. at 711-712.
24
Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45, 66 (1923).

The doctrine of “accidental anticipation” is distinguishable from inherent anticipa-
tion since accidental anticipation requires, as its name implies, an “accidental or unwit-
ting duplication”25
of the invention in the prior art. Practitioners Brown and Polyakov
comment that the “anticipation” moniker of accidental anticipation “is somewhat of a
misnomer because under this doctrine the prior art does not, in fact, anticipate under 35
U.S.C. § 102.”26
Unfortunately, as Brown and Polyakov assert, it is often unclear when a prior occur-
rence falls under the doctrine of accidental anticipation— which is not inherent, and
thus does not render the claimed invention anticipated— or the doctrine of inherent
anticipation— which is inherent, and does render an invention anticipated— because
what constitutes an accident remains undefined, and requires the court to engage in a
specific fact-based inquiry.27
Courts have made it clear, however, that if there is a “possible” or only occasional
occurrence, it is not grounds for anticipation because “[o]ccasional results are not inher-
ent.”28
In contrast, courts have determined that if the prior art discloses a claimed ele-
ment which necessarily, inevitably, and always functions in accordance with, or includes,
the claimed limitations,29
in other words, is a natural result flowing from the operations
as taught,30
the prior art disclosure inherently anticipates.31
For example, in MEHL/Biophile,32
the United States Court of Appeals for the Federal
Circuit (hereinafter “Federal Circuit”) concluded that a laser manual teaching tattoo re-
moval did not inherently anticipate a claimed hair depilation method of aligning a laser
substantially over a hair follicle opening.33
The prior art manual did not expressly teach
the substantial vertical alignment of the laser over a hair follicle as claimed. While there
was a possibility that the laser may be aligned substantially vertically over a hair follicle
during tattoo removal, the MEHL/Biophile court held such occasional results did not con-
stitute inherent anticipation: “The mere fact that a certain thing may result from a given
set of circumstances is not [inherent]. If, however, the disclosure is sufficient to show
that the natural result flowing from the operation as taught would result in the perfor-
mance of the questioned function, it seems to be well settled that the disclosure should
be regarded as [inherent].”34
The fact patterns resulting in a finding of accidental anticipation or inherent anticipa-
tion can be quite close, however. Compare, for example, the holding of In re Marshall35
to In re Cruciferous Sprout Litigation.36
In Marshall, the claims at issue recited a weight control process comprising, to para-
phrase, administering an anesthetic, such as oxethazaine, prior to eating wherein the
25
See, e.g., In re Felton, 484 F.2d 495, 500 (C.C.P.A. 1973); In re Marshall, 578 F.2d 301, 303 (C.C.P.A. 1978).
26
Anne Brown & Mark Polyakov, The Accidental and Inherent Anticipation Doctrines: Where Do We Stand and Where Are We
Going?, 4 J. Marshall. Rev. Intell. Prop. L. 63 (2004). (emphasis added).
27
Id. at 63.
28
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
29
In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986).
30
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
31
See also In re Montgomery, 677 F.3d 1375, 1384 (Fed. Cir. 2012) (Lourie, J., dissenting)(“[a]bsent inevitability, inherency does
not follow even from a very high likelihood that [the prior art] will result in the claimed invention”).
32
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362 (Fed. Cir. 1999).
33
Id. at 1365.
34
Id., quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (C.C.P.A. 1939).
35
In re Marshall, 578 F.2d 301 (C.C.P.A. 1978).
36
In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir. 2002).

quantity of food consumed passes through the digestive tract rather than being absorbed
into the bloodstream.37
The United States Patent and Trademark Office Board of Appeals
(hereinafter “the Board”) affirmed rejection of the claims as anticipated under 35 U.S.C.
§ 102 by the Physician’s Desk Reference (PDR).38
The PDR prescribed oxethazaine for the
treatment of various gastrointestinal disorders to be administered before meals and/or
at bedtime, but did not describe use of oxethazaine for weight control.39
Regardless, the Board found the PDR prescription of oxethazaine before meals in-
herently anticipated the claimed weight control process since patients following the pre-
scribed treatment for their gastrointestinal disorder would also achieve weight control.40
The United States Court of Customs and Patent Appeals (C.C.P.A.) reversed the Board’s
rejection of these claims, reasoning that “[n]othing in the PDR remotely suggests taking
oxethazaine to lose weight. If anyone ever lost weight by following the PDR teachings
it was an unrecognized accident. An accidental or unwitting duplication of an invention
cannot constitute an anticipation.”41
Cruciferous Sprout42
recites a similar fact pattern to Marshall— in each case the pub-
lic was ingesting a known material— but the Cruciferous Sprout court instead held the
claims inherently anticipated. An exemplary claim at issue in Cruciferous Sprout re-
cited a method of “‘reducing the level of carcinogens in a mammal”’ by administering a
harvested cruciferous sprout food product rich in glucosinolates with Phase 2 enzyme-
inducing potential.43
The prior art was a sprouting cookbook espousing the “health giving” benefits of
sprouts, such as broccoli and cauliflower sprouts.44
The Federal Circuit held the claim
inherently anticipated since the newly discovered properties— “ the glucosinolate con-
tent and Phase 2 enzyme-inducing potential”— of such sprouts had necessarily “existed
as long as sprouts themselves, which is certainly more than one year before the date of
application at issue here.”45
The Cruciferous Sprout court used public policy rationale
under 35 U.S.C. § 101 to support this finding of inherency:
[t]he basic provision of Title 35 applicable here is § 101, providing in rele-
vant part: “Whoever invents or discovers any new . . . composition of matter,
or any new . . . improvement thereof, may obtain a patent therefor, subject
to the conditions and requirements of this title . . .” [C]ounsel never came
to grips with the real issues: (1) what do the claims cover and (2) is what
they cover new? Under the laws Congress wrote, they must be considered.
Congress has not seen fit to permit the patenting of an old [material], known
to others through a printed publication, by one who has discovered its . . .
useful properties.46
37
In re Marshall, 578 F.2d 301, 302 (C.C.P.A. 1978) (ingesting oxethazaine prior to eating anesthetizes the nerve endings in the
digestive tract, thereby preventing downstream release of pancreatic enzymes necessary for digestion).
38
Id. at 303.
39
Id.
40
Id. at 304.
41
Id.
42
43
Id. at 1345.
44
Id. at 1350-1351.
45
Id.
46
Id. at 1350, quoting Titanium Metals Corp. v. Banner, 778 F.2d at 780, 782 (Fed. Cir. 1985)(emphasis in the original).

While the plaintiff in Cruciferous Sprout was the first to discover the useful cancer-fighting
properties of the sprouts, these newly discovered properties were necessarily present in
the sprouts, and the public necessarily benefitted from these properties upon ingestion.
Since the newly-discovered property was held inherent and given no patentable weight,
the claims at issue— merely encompassing an old method of ingesting sprouts— were
invalidated as inherently anticipated.47
B. Should Recognition be Required in the Inherency Analysis?
In addition to the difficulty of distinguishing what is an “accidental” from a “necessar-
ily present” occurrence, there remained doctrinal confusion and inconsistent application
over whether a party claiming anticipation need show that a Person Having Ordinary
Skill In The Art (hereinafter, a “PHOSITA”) would have recognized or appreciated—
either contemporaneously or at least before the critical date of the claimed invention48
—
a necessarily present element in order for the prior art disclosure to rise to the level of
inherent anticipation. Professors Burk and Lemley credit Tilghman for the source of this
doctrinal confusion.49
According to Burk and Lemley,
[t]he Court in Tilghman offered two different reasons why the invention
was not inherently anticipated: those of skill in the art did not understand
that it was present in that art [the recognition prong] and the public was not
using or benefiting from the prior use of the process [the necessarily present
prong]. Were both elements required for inherency to attach? Would either
one suffice or prove inherency? Or was one of the factors dominant and other
simply playing a supporting role?50
While courts have repeatedly cited Tilghman as standing for the proposition that inherent
anticipation requires both prongs, “courts frequently ignore[d]— or outright contradict[ed]—
this standard, appearing, rather at least superficially, to only arbitrarily embrace the re-
quirement of recognition of the inherent element by a skilled artisan.”51
For example, in the 1991 Continental Can decision,52
the claims at issue recited a con-
tainer whose bottom structure contained a plurality of hollow ribs. Such ribs allowed
the bottom structure to have sufficient flexibility to impart improved impact resistance,
but also sufficient rigidity to resist deformation under internal pressure.53
The prior art,
U.S. Patent 3,468,44354
described a similar container containing ribs, but was silent with
regard to whether the ribs disclosed were hollow.55
47
Some viewed the Cruciferous Sprout decision, at least with respect to the medical uses of the sprouts, as wrongly
decided. See, e.g., Warren D. Woessner, In re Montgomery- “Unbounded” Inherency, Patents4Life (May 10, 2012),
http://www.patents4life.com/2012/05/in-re-montgomery—“unbounded” inherency/.
48
Supra note 5: The critical date, otherwise known as the date of the inventor’s proof of invention, is the specified date of old
(pre-AIA) 35 U.S.C. §102(a). Under the new (AIA) 35 U.S.C. §102(a)(1), the specified date is now the effective filing date of the
patent application.
49
Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371, 377 (2005).
50
Id.
51
Id. at 379 n.41 (quoting Tracey Davies, Inherent Anticipation: Turning the Written Description Requirement on Its Head, Paper
Presented at the Eighth Annual Advanced Patent Law Inst. 4 (Oct 29, 2003)).
52
Continental Can Co. v. Monsanto Co., 948 F.2d 1264 (Fed. Cir. 1991).
53
Id. at 1266.
54
U.S. Patent No. 3,468,443 (filed Oct. 6, 1967) (hereinafter “the ’443 patent”).
55
Continental Can Co. v. Monsanto Co., 948 F.2d. at 1268.

The court, in consideration of the ’443 patent, while mechanically reciting the two-
prong standard (“[t]o serve as anticipation when a reference is silent about the asserted
inherent characteristic...[the extrinsic] evidence must make clear that the missing descrip-
tive matter is necessarily present in the thing described in the reference, and that it would
be so recognized by persons of ordinary skill”),56
proceeded to only consider whether the in-
jection blow molding process as described in the ’443 patent necessarily produced hollow
ribs. The court simply did not consider whether the inherent hollowness of these prior
art ribs was a feature recognized by a PHOSITA, either contemporaneously or prior to
the critical date of the claimed invention.
In the 1999 Atlas Powder decision,57
the Federal Circuit outright rejected the require-
ment for recognition by a PHOSITA in the inherency analysis:
[i]nherency is not necessarily coterminous with the knowledge of those
of ordinary skill in the art . . . Artisans of ordinary skill may not recognize the
inherent characteristics or functioning of the prior art . . . an insufficient prior
understanding of the inherent properties of a known composition does not
defeat a finding of anticipation.58
However, in the 2002 Rosco decision,59
the Federal Circuit fully embraced the require-
ment for recognition while simultaneously disparaging the necessarily present require-
ment: “[t]he question is not whether the manufacture of the mirror using this process
inherently results in a varying radius of curvature along the major axis, but whether one
skilled in the art would read the [prior art disclosure] as inherently disclosing the invention.”60
Several lines of cases before and after the Rosco decision however, similar to Atlas
Powder, rejected the requirement for recognition by the PHOSITA.61
Professors Mueller and Chisum cite Judge Learned Hand’s opinion in the 1933 H. K.
Regar and Sons decision62
as arguably the “most satisfactory reason why contemporane-
ous recognition should not be required for inherent anticipation.”63
The claims at issue in
Regar recited a method for producing a scalloped edge at the top of knitted stockings.64
The prior art “Wilson stockings” were depicted as scalloped, albeit unintended, since the
scalloping was the result of a “tuck” stitch distortion.65
The plaintiff argued that since
the scalloping in the Wilson stockings was not Wilson’s intended result, the plaintiff’s
claimed method for producing scalloping was not inherently anticipated.66
Judge Hand
disagreed, finding the Wilson stockings, necessarily produced with scalloping via the
intentional “tuck” stitch, were anticipatory under the doctrine:
56
Id. (emphasis added).
57
Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342 (Fed. Cir. 1999).
58
Id. at 1347, 1349 (emphasis added).
59
Rosco, Inc. v. Mirror Lite Co., 304 F.3d 1373 (Fed. Cir. 2002).
60
Id. at 1381 (emphasis added).
61
See, e.g., Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985); Verdegaal Bros. Inc. v. Union Oil Co. of Cal., 814
F.2d 628 (Fed. Cir. 1987); MEHL/Biophile International Corp. v. Milgraum, 192 F.3d 1362 (Fed. Cir. 1999); In re Cruciferous Sprout
Litigation, 301 F.3d 1343 (Fed. Cir. 2002).
62
H.K. Regar & Sons v. Scott & Williams, 63 F.2d 229, 231 (2d. Cir. 1933).
63
See, e.g., Janice M. Mueller & Donald S. Chisum, Enabling Patent Law’s Inherent Anticipation Doctrine, Legal Studies Research
Paper Series (Working Paper No. 2008-19) 1101, 1127-1128 (2008).
64
H.K. Regar & Sons v. Scott & Williams, 63 F.2d at 229 (2d. Cir. 1933).
65
Id. at 230.
66
Id. at 231.

[t]he plaintiff answers that the effect was not intended in the Wilson stock-
ings, and that the invention was not therefore anticipated. It is quite true that
an accidental use will not anticipate a process, if the earlier practiser was not
aware of what he was doing, or how he did it. His work must give some
assurance that the result can be reached another time, and of this there can
be none unless the process is deliberate and the means understood. Nothing
else can be called an art; it is merely an accident . . . But when the result is a
necessary consequence of what was deliberately intended, it is irrelevant that it was
then valueless for the purposes in mind. Were that enough to prevent anticipation,
it would be possible to patent a new use for an unchanged process; which is never
true.67
Judge Hand determined it was inconsequential that Wilson (or another PHOSITA) did
not recognize or appreciate the scalloping in the Wilson stockings prior to plaintiff’s
patent application filing date since the method of Wilson necessarily and always pro-
duced the scalloping, intentional or not. The plaintiff’s method was well within the
public’s grasp prior to his filing date, and it was therefore not possible for the plaintiff to
effectively withdraw from the public a benefit already enjoyed by claiming it.
In seeking to resolve the doctrinal confusion promulgated by Tilghman, Burk and
Lemley68
as well as practitioners Brown and Polyakov69
similarly dispense with the
recognition requirement. Burk and Lemley note that the recognition prong, while often
recited as an element in inherency cases, has never been the determinative outcome of
an appellate case, and thus should not be a factor in the inherent anticipation analysis.70
Burk and Lemley, however, further reject the draconian position that the “necessarily
present” prong be the sole requirement for a finding of inherent anticipation.71
They pro-
pose, instead, the inherency analysis should require a finding that the public has already
gained the benefit of the invention, in addition to the claimed element being necessar-
ily present in the prior product or process.72
If the public has already benefitted from
the invention, even without knowing why, the prior product or process should inher-
ently anticipate; if the public has not benefitted from the invention, the prior product or
process should not inherently anticipate.73
The publication of Brown and Polyakov’s treatise pre-dates Burk and Lemley’s public
benefit theory by a few months, but presents the same type of analysis in decision tree
form.74
The first question Brown and Polyakov propose for a finding of inherent anticipation,
whether the prior product or process was useful in the art, is akin to asking, similar to
Burk and Lemley, whether the public benefitted from the prior art product or process.75
If
the first question is answered in the affirmative, Brown and Polyakov propose the second
67
Id. (emphasis added) (internal citations omitted).
68
Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371 (2005).
69
Anne Brown & Mark Polyakov, The Accidental and Inherent Anticipation Doctrines: Where Do We Stand and Where Are We
Going?, 4 J. Marshall. Rev. Intell. Prop. L. 63 (2004).
70
Burk & Lemley, Inherency, 47 Wm. & Mary L. Rev. 371, 379 (2005).
71
Id.
72
Id.
73
Id.
74
Brown & Polyakov, The Accidental and Inherent Anticipation Doctrines: Where Do We Stand and Where Are We Going?, J. 4
Marshall Rev. Intell. Prop. L. 63, 89 (2004).
75
Id.

question to ask is whether the product was obtained or process occurred under unusual
conditions.76
If the public already benefits from the invention, and such an invention
was not obtained under unusual conditions, according to Brown and Polyakov, the prior
product or process should inherently anticipate.77

C. Schering v. Geneva (2003)
The Federal Circuit, in its 2003 Schering v. Geneva78
panel decision, and with its deci-
sion to deny rehearing en banc,79
attempted to settle the debate of whether or not prior
recognition by a PHOSITA is required. The patent at issue, U.S. Patent 4,659,716,80
claimed descarboethoxyloratadine (DCL), a metabolite of the antihistamine loratadine
(Claritin™). See, e.g., Scheme 1.
The prior art was Schering’s own patent, U.S. Patent 4,282,233,81
soon to expire, claim-
ing loratadine. Generic manufacturers, seeking to market loratadine once the ’233 patent
expired, submitted applications to the Food and Drug Administration (FDA). Because
Schering included the ’716 metabolite patent in the Orange Book listing for loratadine,
the generic manufacturers also certified that the claim to DCL was invalid. Schering
filed suit against the generic manufacturers after receiving notice of the FDA filings. The
District Court, on summary judgment, construed claims of the ’716 patent covered DCL
“in all its forms, including “metabolized within the human body” and “synthetically
produced in a purified and isolated form,”82
and the parties agreed with this claim con-
struction. Applying this construction, the District Court held that while the ’233 patent
did not expressly disclose DCL, since the specification contained boilerplate language
contemplating administration, and since the post-filing data submitted during trial es-
tablished that loratadine necessarily metabolized in vivo to its active principle DCL upon
its administration, the teachings of the ’233 patent inherently anticipated the ’716 patent,
rendering the ’716 metabolite patent invalid.83
On appeal, Schering argued for a prior recognition exception to the inherency doc-
trine, at least for newly discovered, patentably distinct chemical entities:
76
Id.
77
Id.
78
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003).
79
Schering Corp. v. Geneva Pharmaceuticals, Inc., 348 F.3d 992 (Fed. Cir. 2003), petition for review en banc denied.
80
U.S. Patent No. 4,659,716 (filed Mar. 12, 1986)(hereinafter “the ’716 patent”).
81
U.S. Patent No. 4.282,233 (filed Jun. 19, 1980)(hereinafter “the ’233 patent”).
82
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373, 1376 (Fed. Cir. 2003).
83
Id.


Scheme 1
DCL is not an old product or process that Schering sought to re-patent
based on some previously unknown property, ingredient or effect that does
not distinguish it over the prior art. Rather, DCL is a new composition of
matter that is patentably distinct . . . Because DCL is a patentably distinct
composition of matter, prior recognition of DCL as existing in the prior art is
required to invalidate under § 102(b).84
The Federal Circuit acknowledged this was “a case of first impression” since this was
the first time the court held inherent the entire recitation claimed.85
However, the Fed-
eral Circuit emphatically rejected the notion that inherent anticipation of the claim to
DCL requires knowledge and recognition of its chemical structure by a PHOSITA be-
fore the critical date of the invention, citing Cruciferous Sprout,86
MEHL/Biophile,87
and
Atlas Powder88
in support.89
The Federal Circuit determined, based on the post-filing
evidence submitted, that DCL did not form accidentally or under unusual conditions,
but rather formed necessarily and inevitably in vivo from the metabolism of loratadine.90
The Federal Circuit further held the boilerplate language in the ’233 patent, describing
the administration and formulation of loratadine, sufficiently enabled DCL to be within
the public’s grasp prior to the critical date of the ’716 patent, stipulating that “[t]o qualify
as an enabled reference, the ’233 patent need not describe how to make DCL in its iso-
lated form . . . [but] need only describe how to make DCL in any form encompassed by a
compound claim covering DCL, e.g., DCL as a metabolite in a patient’s body.”91
In other
words, Schering could not later claim the metabolite DCL since the public, following the
teachings of the ’233 patent, already fully possessed the DCL upon administration of lo-
ratadine, regardless of whether such possession was actual or prophetic, and regardless
of whether the public had no knowledge of DCL’s existence.
84
Brief for Plaintiff-Appellant Schering Corp. at 8, Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir.
2003).
85
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d at 1378 (Fed. Cir. 2003).
86
87
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362 (Fed. Cir. 1999).
88
Atlas Powder Co. v. Ireco, Inc., 190 F.3d at 1348-1349 (Fed. Cir. 1999).
89
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d at 1377 (Fed. Cir. 2003).
90
Id. at 1378.
91
Id. at 1381.

The Federal Circuit was cognizant of the impact this holding would have on the phar-
maceutical industry since claiming metabolites was one way of evergreening a pharma-
ceutical patent portfolio.92
For example, extending the monopoly over a particular drug
by claiming the metabolite of that drug was simply not possible after Schering. The Fed-
eral Circuit indicated however, using proper claim language, patent protection may still
be available for metabolites of known drugs, such as claiming the pure and isolated form
of the metabolite, claiming the pharmaceutical composition of the metabolite, and claim-
ing the method of using the metabolite, if such claims were desirable to the patentee.93
Recent case law has seen it fit to modify the Schering court’s advice: a claim to a
pure and isolated metabolite is presently deemed unpatentable subject matter under 35
U.S.C. § 101 in light of the recent Myriad decision.94
Myriad held that “isolated” language
in a composition of matter claim reciting “isolated DNA” does not render that claim to
the natural DNA patentable under 35 U.S.C § 101,95
and the USPTO 2014 Guidance96
in
light of Myriad, extended the Supreme Court’s holding to all natural products, including
metabolites.
II. After Schering
A. The Schering Dissenters
Judges Newman and Lourie filed separate opinions sharply dissenting the Schering court’s
denial of rehearing en banc.97
Judge Newman primarily objected to the majority’s lack
of deference to established precedent, pointing out that all of the inherency cases before
Schering found inherency only in situations where a single undisclosed limitation of a
claimed invention was necessarily present.98
In contrast, the Schering decision extended
inherency to claimed subject matter completely undisclosed and unknown in the prior
art: “[n]o precedent supports the position that a product whose existence was not pre-
viously known and is not in the prior art is always unpatentable on the ground that it
existed undiscovered. If the law is to be changed in this direction it must be done en
banc.”99
In his dissent, Judge Lourie objected to majority’s finding that the mere description
of administering and formulating a pharmaceutical product using boilerplate language
enabled disclosure of the product’s unknown metabolites:
[i]f U.S. Patent 4,282,233 really taught how to make metabolites, it might
be another story. However, that patent simply included a minimal boilerplate
92
See, e.g., Alfredo De La Rosa, A Hard Pill to Swallow: Does Schering v. Geneva Endanger Innovation Within the Pharmaceutical
Industry? 8 Colum. Sci. & Tech. L. Rev. 37 (2007), http://www.stlr.org/cite.cgi?volume=8&article=2 (discussing the repercussions
the patent community feared would result from the Schering decision).
93
Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d at 1381.
94
Association for Molecular Pathology v. Myriad Genetics, Inc., 133 U.S. 2107 (2013).
95
Id. at 2118.
96
U.S. Pat. & Trademark Office, 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving
Laws Of Nature /Natural Principles, Natural Phenomena, And/Or Natural Products (Mar. 4, 2014) (hereinafter “Guidance”),
superseded by U.S. Pat. & Trademark Office, 2014 Interim Guidance on Patent Subject Matter Eligibility (Dec. 16, 2014).
97
Schering Corp. v. Geneva Pharmaceuticals, Inc., 348 F.3d 992 (Fed. Cir. 2003), petition for rehearing en banc denied.
98
Id. at 993.
99
Id.

statement of how to use the claimed products, sufficient to satisfy the require-
ments of 35 U.S.C. § 112, but far from the careful and thorough prescribing
information required by the FDA . . . That is hardly an enabling disclosure of
how to make any metabolites, whatever they might turn out to be, sufficient
to anticipate them by inherency.100
Lourie argued that the metabolite DCL was not in “actual public use” by this boilerplate
disclosure, and thus the patentability of DCL should not be precluded under the doctrine
of inherent anticipation.101
Judges Newman and Lourie have repeatedly dissented in various inherency cases
post-Schering,102
and their dissents following two of these decisions, SmithKline Beecham
Corp. v. Apotex Corp103
decided in 2005, and In re Omeprazole Patent Litigation104
decided
in 2008, are exemplary of their continued disagreement with Schering and its application.
Regardless, as of this writing,105
of the Federal Circuit cases citing the Schering decision,
none question its result, i.e., that recognition is no longer required, that inherency may
be extended to completely undisclosed or unknown subject matter, and that an enabling
disclosure rather than an actual presence may be sufficient for establishing inherent antic-
ipation. Furthermore, at least at the time of this writing, the precepts of Schering remain
good law since such panel decisions may only be overruled by the en banc Federal Circuit
or the Supreme Court.
B. SmithKline Beecham Corp. v. Apotex Corp. (2005)
In the 1970s the chemical company Ferrosan sought and obtained U.S. Patent 4,007,196106
claiming 3-substituted-1-alkyl-4-fluorophenyl-piperidines, including a compound later
known as the anti-depressant paroxetine.107
The ’196 patent generally described the
preparation of salts of these compounds, such as the hydrochloride and maleate salts,
and specifically disclosed and characterized the crystalline maleate salt of paroxetine.108
See, e.g., Figure 1. Ferrosan later produced the hydrochloride salt form of paroxetine
(hereinafter “PHC”), although with some difficulty, as the crystalline hydrochloride salt
without bound water molecules (“PHC anhydrate").109
After the ’196 patent and related technology were licensed to SmithKline Beecham,
during experiments to improve PHC production, SmithKline scientists discovered a new
PHC crystalline form with one bound water molecule for every two PHC molecules
(“PHC hemihydrate”) which they found more stable, and thus more easily packaged and
preserved, than PHC anhydrate.110
Interestingly, the scientists also found that batches of
100
Id. at 996.
101
Id. at 996.
102
See, e.g., SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1334 (Fed. Cir. 2005) (Newman, J., dissenting); In re
Omeprazole Patent Litigation, 536 F.3d 1361, 1365 (Fed. Cir. 2008) (Newman, J., dissenting); In re Montgomery, 677 F.3d 1375 (Fed.
Cir. 2012) (Lourie, J., dissenting).
103
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331 (Fed. Cir. 2005).
104
In re Omeprazole Patent Litigation, 536 F.3d 1361, 1365 (Fed. Cir. 2008).
105
Results provided from a Westlaw search of all Federal Circuit cases citing Schering.
106
U.S. Patent No. 4,007,196 abstract (filed Jul. 23, 1975)(hereinafter “the ’196 patent”).
107
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1334 (Fed. Cir. 2005).
108
Id.
109
Id.
110
Id.


Figure 1
PHC anhydrate, when “seeded” (contaminated) with the more stable PHC hemihydrate
form, naturally converted to the hemihydrate form.111
See, e.g., Scheme 2.
Furthermore, the scientists found after this initial seeding experiment it became im-
possible to produce pure PHC anhydrate in the general environment of the laboratory
since any anhydrate formed — presumably now exposed to trace PHC hemihydrate
crystals— morphed to the hemihydrate over time (later dubbed “the disappearing poly-
morph theory”).112
SmithKline rationalized that the PHC hemihydrate was a novel form
which did not exist prior to 1984 since there was no evidence of PHC hemihydrate con-
tamination of early batches of PHC anhydrate and the early batches remained stable and
did not convert to PHC hemihydrate.113
SmithKline Beecham filed and obtained U.S. Patent 4,721,723, claim 1 simply recit-
ing: “Crystalline paroxetine hydrochloride hemihydrate.”114
In 1993, SmithKline, af-
ter obtaining FDA approval, started marketing and selling PHC hemihydrate under the
tradename Paxil™.115
Following expiration of the ’196 patent, the generic manufacturer
Apotex filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking
approval to market generic PHC as the PHC anhydrate.116
The ANDA filing included a certification that Apotex did not infringe the ’723 hemi-
hydrate patent.117
SmithKline subsequently filed suit against Apotex on the basis of the
ANDA filing, alleging under their “disappearing polymorph theory” that Apotex, by
manufacturing and selling anhydrous PHC, infringed claim 1 of the ’723 patent since
“PHC anhydrate tablets inevitably convert to hemihydrate when combined with mois-
ture, pressure, and practically ubiquitous PHC hemihydrate seeds.”118
The resulting litigation between Schering and Apotex eventually made its way to the
Federal Circuit upon appeal, and a three-judge panel deemed claim 1 of the ’723 patent
inherently anticipated by the prior disclosure of the ’196 patent.119
Both parties submit-
111
Id.
112
Id. at 1335, 1336.
113
Id. at 1345.
114
U.S. Patent No. 4,721,723 (filed Oct. 23, 1986)(hereinafter “the ’723 patent”).
115
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d at 1334
116
Id.
117
Id.
118
Id. at 1336.
119
Id. at 1343.


Scheme 2
ted conflicting evidence, including conflicting expert testimony, concerning whether or
not the PHC hemihydrate existed before the critical date of the ’723 patent.120
Particularly telling to the Federal Circuit was SmithKline’s failure to offer any ev-
idence that pure PHC anhydrate could be produced in facilities uncontaminated with
PHC hemihydrate.121
SmithKline’s explanation that it had been manufacturing PHC an-
hydrate according to ’196 patent for years before the hemihydrate was first detected in
1995 did not persuade the Federal Circuit that the hemihydrate was a novel crystalline
form, the court noting that “existence and detection are not the same thing.”122
The Federal Circuit pointed to the District Court’s reasoning that “PHC hemihydrate
may have existed in undetectable amounts since Ferrosan first produced PHC anhydrate
in the 1970s, particularly because the technology to detect PHC hemihydrate in small
amounts did not exist until 1985.”123
Reconciling conflicting expert testimony in favor
of Apotex, the Federal Circuit determined “that it may also be possible for PHC anhy-
drate to coexist with low levels of PHC hemihydrate without further conversion,” at least
when the PHC hemihydrate is present in “small amounts.”124
Applying Schering, the Federal Circuit reasoned the “doctrine of inherent anticipation
applies to the entire claimed subject matter just as it does to a single claimed feature”
and that “inherent anticipation does not require a person of ordinary skill in the art to
recognize the inherent disclosure in the prior art at the time the prior art is created.”125
Further following Schering’s reasoning that “[a]nticipation does not require the actual
creation or reduction to practice of the prior art subject matter; anticipation requires only
an enabling disclosure,”126
the Federal Circuit indicated it was irrelevant to speculate on
whether the hemihydrate existed prior to the critical date of the ’723 patent since the ’196
patent provided sufficient enabling and anticipating disclosure.127
Pointing to the record as clear and convincing, the Federal Circuit further reasoned
production of PHC anhydrate, following the methods taught in the ’196 patent, always
120
Id. at 1345.
121
Id.
122
Id.
123
Id.
124
Id.
125
Id. at 1343 (citations omitted).
126
Id. at 1344 (citing Schering Corp, 339 F.3d at 1380).
127
Id.

and necessarily results in at least trace amounts of the PHC hemihydrate, and thus the
’196 disclosure rendered the claim to the “bare compound PHC hemihydrate” invalid
as inherently anticipated under 35 U.S.C. § 102(b).128
Following Schering’s example, the
Federal Circuit concluded “a patentee may obtain patent protection for an inherently
anticipated compound through proper claiming.”129
Judge Newman,130
in the order declining to hear the case en banc,131
not surprisingly
argued the court’s finding of inherent anticipation in error:
[t]here is no evidence to support the panel’s current finding that the ’196
patent “discloses in an enabling manner the production of the PHC hemihy-
drate” . . . The evidence before the District court did not show that disclo-
sure and enablement, and did not show that the hemihydrate was produced
in 1975, even inherently and undetected. The discovery of the hemihydrate
a decade later, and the “seeding” of subsequent production in this crystal
form, does not provide retrospective knowledge of this then-unknown com-
pound. The not-unique situation that the air of the manufacturing plant is
now seeded with the hemihydrate crystal form does not mean that this sit-
uation existed when the anhydrous product was discovered and the patent
application thereon was filed.132
Newman, seeing the Federal Circuit once again straying from long-established prece-
dent, fervently argued for reinstatement of the recognition prong to the inherency anal-
ysis, at least with regard to application of inherency to the entire scope of subject matter
claimed:
[i]nvalidity based on anticipation under 35 U.S.C. § 102 requires that the
identical invention was known or its existence would reasonably have been
known to a person of ordinary skill in the field of the invention - not that it
might have lain hidden in minuscule amount, undetected, unsuspected, and
unknown . . . Only after a compound is identified does it become subject to
patenting; if its existence is not reasonably known to persons of skill in the
field, its later discovery cannot be retrospectively “inherently anticipated.”133
C. In re Omeprazole Patent Litigation (2008)
Omeprazole, better known as the heartburn medication Prilosec®, inhibits gastric acid
secretion through a complex mechanism via absorption in the intestinal lining. See, e.g.,
Figure 2. Omeprazole is, however, quite sensitive to acid, and thus the oral formulation
must be designed to protect omeprazole from contact with gastric juices in the stomach
prior to absorption in the intestine.134
128
Id. at 1346.
129
Id.
130
Judge Lourie did not participate.
131
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1328 (Fed. Cir. 2005), petition for rehearing en banc denied.
132
Id. at 1329-1330 (internal citations omitted).
133
Id. at 1330.
134
See, e.g., In re Omeprazole Patent Litigation, 536 F.3d 1361, 1365 (Fed. Cir. 2008); In re Omeprazole Patent Litigation, 483 F.3d
1364, 1367 (Fed. Cir. 2007).


Figure 2
A Swedish corporation, Aktiebolaget Hässle, a wholly-owned subsidiary of AstraZeneca
AB (hereinafter “Astra”), sought to develop an oral omeprazole formulation which would
have sufficient gastric acid resistance and long-term shelf life.135
Such a task, however,
proved difficult because the two goals appeared antithetical: protecting omeprazole from
gastric acid in the stomach required an enteric coating, but typical enteric coatings con-
tained acidic compounds that would degrade omeprazole over time due to direct contact
with the drug core.136
Furthermore, alkaline reacting compounds (“ARCs”), typically
added to the drug core to increase stability of the drug product, were found to chemically
interact with and degrade the acidic enteric coating.137
After much experimentation, the
Astra scientists discovered employing an inert sub-coating between the enteric coating
and the drug core solved both goals of increased shelf-life and stability, and subsequently
filed and obtained two patents, U.S. Patent 4,786,505138
and U.S. Patent 4,853,230139
cov-
ering this three-layer formulation.140
The Astra scientists later discovered that such an inert sub-coating may be produced
in situ, during the formulation process, by reaction of two layers, the acidic enteric coat-
ing with the basic ARCs in the drug core, to create a third separating (water soluble salt
form) layer provided certain conditions were controlled, such as low inlet air tempera-
ture (e.g., below 42 ºC), air flow, atomizer air flow, and spraying rate.141
Astra, at the time of this discovery, was aware of a Korean patent application by the
Korean company Chong Kun Dan Corporation (CKD) (the “CKD Patent Application”)
describing production of an omeprazole formulation (Method A) comprising L-arginine,
microcrystalline cellulose, SLS, corn starch and magnesium stearate as the drug core, and
an enteric coating containing HPMCAS, ethyl citrate, talc, and sorbitan sesquioleate, and
whose stability relied on the zwitterionic amino acids (like L-arginine) within the core.142
The CKD Patent Application notably expressly disavowed the presence of a sub-
coating between the drug core and enteric coating, and did not disclose any enteric
coating process conditions.143
Furthermore, after CKD provided Astra with their in-
ternal protocol for manufacturing their CKD omeprazole (OMP) product, Astra deter-
mined the CKD OMP manufacturing process did not result in an in situ sub-coating,
135
In re Omeprazole Patent Litigation, 536 F.3d at 1373.
136
Id. at 1365.
137
Id.
138
U.S. Patent No. 4,786,505 (filed Apr. 20, 1987)(hereinafter “the ’505 patent”)
139
U.S. Patent No. 4,853,230 (filed Apr. 20, 1987)(hereinafter “the ’230 patent”)
140
In re Omeprazole Patent Litigation, 536 F.3d at 1365.
141
Id. at 1368.
142
Id. at 1368, 1369, 1370.
143
Id. at 1370.

presumably due to the high inlet air temperature (e.g., 70 ºC) used following the CKD
protocol.144
Considering the Astra formulation produced in situ novel and non-obvious
over the process described in the CKD Patent Application, Astra filed and obtained U.S.
Patent 6,013,281.145
Claim 1 of the ‘281 patent, in its entirety, recites:
1. A process for preparing an oral pharmaceutical formulation comprising
the steps of:
forming a core material comprising a proton pump inhibitor and at least
one alkaline reacting compound [ARC], wherein the concentration of the al-
kaline reacting compound is about 0.1 mmol/g dry ingredients in the alkaline
containing part of the core material, and
applying an enteric coating polymer layer so as to surround the core mate-
rial thereby forming in situ a separating layer as a water soluble salt product
between the alkaline compound and the enteric coating polymer.146
Astra filed suit against several generic pharmaceutical manufacturers, including Andrx
Pharmaceuticals, Inc., asserting infringement of the ’281 patent.147
The District Court
found the ’281 patent inherently anticipated by the CKD Patent Application and thus
invalid under 35 U.S.C. § 102(b), and the Federal Circuit affirmed the District Court’s
decision.148
Interestingly, this finding of inherency was based primarily on assertions Astra made
in prior proceedings in the Korean Intellectual Property Office (KIPO) over infringe-
ment of the Korean counterpart to the three-layer ’505 patent.149
The KIPO proceedings
turned on whether the omeprazole formulation provided in the CKD Patent Applica-
tion, and which encompassed the omeprazole product CKD was marketing, contained a
sub-coating between the drug core and enteric coating.
CKD pointed out during these proceedings that the method described in the CKD Ap-
plication (Method A) did not involve a separate third step to make a sub-coating.150
In
response, Astra countered that the omeprazole formulation described in the CKD Patent
Application forms an in situ sub-coating layer “each and every time” due to the instanta-
neous reaction of HPMCAS (provided in the enteric coating) with L-arginine (provided
within the drug core).151
In the suit at hand, Astra did not attempt to deny their previous assertions.152
Instead,
Astra argued that the CKD Patent Application could not render the claims of the ’281
patent inherently anticipated since the claim language “forming an in situ layer” was
not explicitly described in the CKD Patent Application; the teachings of the ’281 patent
required that the claimed invention be performed at a temperature below 42 ºC in order
for the in situ sub-coating to form; and such a low temperatures were not specifically
taught by the CKD Patent Application.153
144
Id. at 1369.
145
U.S. Patent No. 6,013,281 (filed Feb. 9, 1996)(hereinafter “the ’281 patent”).
146
In re Omeprazole Patent Litigation, 536 F.3d. at 1367, 1368. Of note is that claim 1 is not limited to a low inlet air temperature.
147
Id. at 1366.
148
Id.
149
Id. at 1368.
150
Id.
151
Id. at 1372.
152
Id.
153
Id. at 1371.

The Federal Circuit agreed with the District Court that Astra’s arguments were unper-
suasive since claim 1 of the ’281 patent was not limited to any temperature and the ’281
patent specification suggested not just below 42 º C but also other variable temperatures
for producing the in situ formulation.154
Astra’s argument that the CKD Application
did not disclose or perform the method at the low required temperature of 42 º C or be-
low was thus disregarded as irrelevant. Furthermore, citing Schering, the Federal Circuit
determined that although the Astra scientists “may not have recognized that a character-
istic of CKD’s Method A ingredients, disclosed in the CKD Patent Application, resulted
in an in situ formation of a separating layer, the in situ formation was inherent.”155
The Federal Circuit further agreed with the District Court that, while the CKD Patent
Application did not explicitly recite formation of the in situ layer, and even disavowed its
formation, the assertions Astra made during the KIPO proceedings provided sufficient
basis for a finding of inherency:
[t]he record shows formation of the in situ separating layer in the prior art
even though that process was not recognized at the time . . . Despite CKD’s
denials, [Astra’s scientists] realized and explained that CKD’s OMP tablet’s
formation of a separating layer was a natural result flowing from the com-
bination of certain ingredients listed in Method A . . . The ingredients and
protocols CKD gave to the KIPO and Astra in 1993 and 1994 necessarily re-
sulted in in situ formation of a separating layer. Thus, the trial court correctly
found inherent anticipation.156
Newman again dissented, chalking this inherency finding up to a “flawed analysis”157
since the court invalidated a patent directed to a unknown process as anticipated:
[t]he Astra process is not described in the prior art, although Astra admit-
ted that it believed that the Korean company Chong Kun Dan Corporation
(CKD) had made such a product. It is not disputed that such a sublayer does
not form under the conditions in the CKD patent application. No such re-
action is described in CKD’s Korean patent application, nor the conditions
that could have produced such a product. Nonetheless, my colleagues rule
that the process discovered by Astra is “inherently anticipated” by the CKD
application. That is not the law of either anticipation or inherency. I must,
respectfully, dissent.158
Newman further argued that in her view the CKD Patent Application lacked sufficient
enablement to provide the in situ separating layer since the application did not describe
the low temperature required for its formation:
All parties agree that the closest prior art is the Korean CKD application. It
was not disputed that the ingredients of the Astra and the CKD omeprazole
formulations are the same standard enteric ingredients . . . However, no
reference describes the conditions by which Astra produced an in situ interior
154
Id. at 1372.
155
Id. at 1373.
156
Id.
157
Id. at 1376.
158
Id. at 1377.

sublayer. No reference suggests formulation temperatures at or below 42°C,
or that such a sublayer might form at such low temperatures.159
III. Inherent Anticipation Applied to Obviousness
In the wake of the In re Omeprazole Patent Litigation decision,160
in which (some argued)
enabled subject matter rather than “necessarily present” subject matter was deemed in-
herent, the patent community expressed concern over whether the doctrine of inherency
– by “simply turn[ing] what used to be an obviousness rejection into an inherent antic-
ipation rejection” – was impermissibly expanding into the obviousness inquiry.161
Such
an expansion would indeed be significant because “an applicant or patentee facing an
anticipation rejection cannot rebut it with evidence of secondary considerations (such as
unexpected results or commercial success) in contrast to an obviousness rejection where
such secondary considerations are relevant.”162
Part of this confusion stemmed from sev-
eral Federal Circuit cases decided between 1966 to 1993 maintaining a clear distinction
between the concepts of inherency and obviousness,163
repeatedly reversing findings of
obviousness which used inherency as part of the rejection, reasoning “[t]hat which may
be inherent is not necessarily known; obviousness cannot be predicated on what is un-
known.”164
The Federal Circuit has since clarified its position, first in the “reverse in-
herency” In re Dillon decision,165
and most recently via a series of cases decided between
2011 and 2014 affirming the doctrine of inherent anticipation may indeed be applicable
within the obviousness inquiry: In re Kao,166
Allergan v. Sandoz,167
and Par Pharmaceutical,
Inc. v. Twi Pharmaceuticals, Inc.168,169,170
While each of the above-referenced cases will be examined further below, an initial
159
Id. at 1379.
160
As well as other decisions; see, e.g., Upsher-Smith Laboratories Inc. v. PamLab LLC, 412 F.3d 1319 (Fed. Cir. 2005); Perricone
v. Medicis Pharmaceutical Corp., 432 F.3d 1368 (Fed. Cir. 2005); and Abbott Laboratories v. Baxter Pharmaceutical Products Inc., 471
F.3d 1363 (Fed. Cir. 2006).
161
See pages 442-444 of Robert Shulman, David Kelly & Alexander Spiegler, “Recent Trends in Patent Practice: The Federal
Circuit’s Treatment of Pharmaceuticals,” Life Sciences Law & Indus. 442-448 (2007).
162
Id. at 443.
163
See, e.g., In re Shetty, 566 F.2d 81, 86 (C.C.P.A. 1977) (“[T]he inherency of an advantage and its obviousness are entirely
different questions. That which may be inherent is not necessarily known. Obviousness cannot be predicated on what is
unknown” - reversing obviousness rejection)(citing In re Spormann, 363 F.2d 444, 448 (C.C.P.A. 1966)); W.L. Gore & Associates, Inc.
v. Garlock, Inc., 721 F.2d 1540, 1555 (Fed. Cir. 1983) (“Inherency and obviousness are distinct concepts” - reversing obviousness
rejection based on erroneous conclusion that prior art reference described a process that inherently would produce the claimed
product invention); In re Grasselli, 713 F.2d 731, 739 (Fed. Cir. 1983) (“obviousness cannot be predicated on what is unknown”
- reversing USPTO’s rejection of the claims as obvious over inherent aspects of the prior art); Jones v. Hardy, 727 F.2d 1524, 1529
(Fed. Cir. 1984) (“though anticipation is the epitome of obviousness, [they] are separate and distinct concepts”); In re Rijckaert,
9 F.3d 1531, 1534 (Fed. Cir. 1993) (“[A] retrospective view of inherency is not a substitute for some teaching or suggestion
supporting an obviousness rejection” - reversing obviousness rejection because USPTO had failed to establish a prima facie case
of obviousness).
164
In re Spormann, 363 F.2d 444, 448 (C.C.P.A. 1966).
165
919 F.2d 688 (Fed. Cir. 1990).
166
639 F.3d 1057, 1070 (Fed. Cir. 2011).
167
726 F.3d 1286, 1296 (Fed. Cir. 2013, rehearing en banc denied, Dyk, J., dissenting).
168
773 F.3d 1186 (Fed. Cir. 2014).
169
See also In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995), not discussed, but one of the earliest cases to articulate “an inherent
teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.”
170
See also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2013, rehearing en banc denied), not discussed, but,
following a similar rationale as laid out in Kao, used inherency to render a claim invalid as obvious.

spoiler may be helpful: the Federal Circuit has maintained in these recent decisions that
establishing a prima facie case of obviousness first requires a finding of motivation or ap-
parent reason to combine or modify the prior art to arrive at the claimed invention,171
and
that finding a particular claim limitation or newly discovered property of the claimed
subject matter as inherent— thus without patentable weight— should only come after
that motivation is established. In other words, absent an articulated motivation or reason
to combine based within the confines of the prior art, the doctrine of inherent anticipation
should not be applied.
A. In re Dillon (1990) and the Concept of “Reverse Inherency”
In re Dillon172
provides one example of how inherent anticipation can become a signif-
icant and troublesome factor in attempting to overcome an obviousness rejection. Dil-
lon filed a patent application encompassing hydrocarbon fuel compositions based upon
his discovery that inclusion of a known class of structurally related compounds, tri-
orthoesters and tetraorthoesters, into hydrocarbon fuel compositions reduced soot emis-
sion upon combustion.173
See, e.g., Figure 3.
The claims at issue— directed towards the tetraorthoester hydrocarbon fuel compo-
sitions174
— were initially rejected as obvious by the Board. The primary prior art cited,
two U.S. patents, described hydrocarbon fuel compositions containing triorthoesters but
did not explicitly teach the use of tetraorthoester hydrocarbon fuel compositions.175
A secondary prior art reference taught that the triorthoesters and tetraorthoesters
were chemically equivalent, at least when used as water scavengers in hydraulic (e.g.,
non-hydrocarbon) fluids.176
Based on a combination of the primary and secondary ref-
erences, and the close structural and chemical similarity between these two classes of
compounds, the Board found that a PHOSITA, acquainted with the prior art of record,
would have a reasonable expectation for the tetraorthoesters to have properties similar to
the triorthoesters, such as water scavenging properties, sufficient to provide a motivation
to make the claimed compositions.177
The Board held since Dillon did not submit evidence of an unexpected advantage or
superiority of the claimed tetraorthoester fuel compositions, the tetraorthoester fuel com-
position claim was unpatenable as obvious.178
Dillon and her assignors subsequently
appealed the Board’s decision to the Federal Circuit.179
The Federal Circuit affirmed the Board’s decision en banc, finding the prior art refer-
ences provided sufficient motivation to make the claimed tetraorthoester hydrocarbon
fuel compositions, albeit based on a different reason taught in the art (water scavenging
171
See, e.g., Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., No. CCB-11-2466, slip op. at 26 (D. Md. Feb. 21, 2014) (citing
In re Newell 891 F.2d 899 (1989), indicating that if no motivation to combine the prior art other than the inventor’s discovery,
reliance on the inherency of the problem or improvement to find the invention obvious is improper).
172
In re Dillon, 919 F.2d 688 (1990).
173
Id. at 690-691.
174
A method of reducing the emissions using tetraorthoester hydrocarbon fuel compositions was also claimed by Dillon, but
the Board, and well as the Federal Circuit, reviewed only the merits of the composition claims. See Dillon at 692.
175
Id. at 691.
176
Id.
177
Id.
178
Id.
179
Id.


Figure 3
properties) from the inventor’s discovery (reducing soot emissions).180
The Federal Cir-
cuit held that once a prima facie case of obviousness is established, and where the prior
art gives a reason or motivation to make the claimed compositions, “the burden (and
opportunity) then falls on the applicant to rebut that prima facie case. Such rebuttal or
argument can consist of a comparison of test data showing that the claimed composi-
tions possesses unexpectedly improved properties or properties that the prior art does not
have.”181
Since Dillon did not (and presumably could not)182
present such rebuttal evi-
dence, the Federal Circuit held the claimed composition obvious.
The rebuttal evidence in Dillon— demonstrating the structurally similar prior art
compositions did not have the same properties as the claimed compositions— was later
dubbed by Burk and Lemley as “reverse inherency” or “inherent absence.”183
Such evi-
dence, in essence, requires the applicant to demonstrate the properties of the new com-
position are not inherently present in the prior art composition.184
An applicant who
discovers a new use of a new but structurally similar composition thus may shoulder
a heavier burden than most if the applicant cannot produce sufficiently persuasive ev-
idence of unexpectedly improved properties, since the applicant must then prove the
absence of those properties in the prior art.185
Dillon, according to Burk and Lemley, can be likened to Cruciferous Sprout, albeit
within the context of obviousness rather than anticipation:
Like the patentee there, Dillon identified a previously unknown but in-
herent property; the difference is that she claimed a new but structurally ob-
vious chemical. Because people would have been motivated to make the new
chemical for the same reason as they made the old one, the only way Dil-
lon could show patentability would be to demonstrate a new property of the
new chemical. Because it turned out that the old chemical inherently had
the property she identified, her chemical was held an obvious variant of the
old.186
180
Id. at 692. Note the Federal Circuit and the Board did not find the inventor’s discovery of a new use relevant in exam-
ination of the composition claims since these claims were not limited to that use. Furthermore, the Federal Circuit held that
the inventor’s discovery of this new use cannot defeat an obviousness rejection over a composition claim, see, e.g., Dillon at
693:“[T]he discovery that a claimed composition possesses a property not disclosed for the prior art subject matter does not
itself defeat a prima facie case...the statement that a prima facie obviousness rejection is not supported if no reference shows or
suggests the newly-discovered properties and results of a claimed composition is not the law.”
181
Id. at 692-693 (emphasis added).
182
In fact, Dillon’s specification provided data showing the prior art compositions containing triorthoesters had equivalent
activity to the tetraorthoesters in reducing particulate emissions. See, e.g., Dillon at 694.
183
See, e.g., Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371, 396-400 (2005).
184
Id.
185
Id.
186
See Dan L. Burk & Mark A. Lemley, Inherency, 47 Wm. & Mary L. Rev. 371, 398 (2005).

B. Recent Application of Inherency to Obviousness: 2011 to present
In re Kao,187
Allergan v. Sandoz,188
and Par Pharmaceutical, Inc. v. Twi Pharmaceuticals,
Inc.189
are examples of how inherency may be applied during the obviousness inquiry
rather than, as in Dillon, afterwards in rebuttal. Each of the claims at issue relied on func-
tional language as the singular distinguishing feature over the prior art. Furthermore,
in each case the court proceeded to determine whether this recited functional claim lan-
guage was or was not an inherent property. If so found, the functional language was
given no patentable weight, thereby rendering the claimed invention obvious.
1. In re Kao (2011) and Par Pharmaceutical (2014)
The facts of Kao190
and Par Pharmaceutical191
share many similarities. In each case, the
inventors were confronted with the problem of poor bioavailability of a particular drug
upon administration: oxymorphone in Kao and megestrol acetate in Par Pharmaceutical.192
In each case, the inventors discovered improved drug bioavailability with use of a
particular formulation: a controlled release (CR) formulation in Kao and megestrol ac-
etate as a nanoparticulate suspension in Par Pharmaceutical.193
In each case, the inventors
discovered a particular “food effect” associated with the formulation: in Kao, the inven-
tors found improved bioavailability upon administering the CR formulation with food,
while in Par the inventors found improved bioavailability of the nanoparticulate suspen-
sion such that no substantial difference was observed in the fed versus fasted state.194
Furthermore, in each case the claims at issue recited the associated “food effect” dis-
covery using functional language.195
However, in Kao, the recited functional language
was found inherent, while in Par, the recited functional language was not so found. As
to be expected, the different outcome of each case turned on whether or not the recited
functional limitation was a “necessary result” of what was described in the prior art.196
In re Kao In Kao, the Board rejected claims of three pending U.S. Patent Applications as
obvious. Claim 8 of one such pending application, U.S. Patent Application 12/167,859
recites:
8. A method for treating pain in a human subject in need of acute or chronic
pain relief, comprising the steps of:
187
639 F.3d 1057, 1070 (Fed. Cir. 2011, rehearing en banc denied).
188
726 F.3d 1286, 1296 (Fed. Cir. 2013, rehearing en banc denied, Dyk, J., dissenting).
189
773 F.3d 1186 (Fed. Cir. 2014).
190
In re Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011, rehearing en banc denied).
191
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., CCB-11-2466, slip op. at 13 (D. Md. Feb. 21, 2014); Par Pharmaceutical,
Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186 (Fed. Cir. 2014).
192
See In re Kao at 1062 and Par Pharmaceutical slip op. at 1.
193
Id.
194
195
196
See In re Kao at 1069 and Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186, 1194-1196 (Fed. Cir. 2014). In
fact, in Kao, as discussed in more detail below, there was only one prior art reference that taught each of the non-functional
limitations at least for the broadest claim at issue, thus, the claims at issue in Kao might have been properly invalidated as
inherently anticipated under 35 U.S.C. §102 rather than as obvious under 35 U.S.C. §103. See, In re Kao at 1069, indicating the
prior art Maloney reference taught each non-functional limitation.


Figure 4
(a) providing a solid oral dosage form comprising about 5 mg to about 80
mg oxymorphone or a pharmaceutically acceptable salt thereof in a controlled
release delivery system with a release rate profile designed to provide an ad-
equate blood plasma level over at least 12 hours to provide sustained pain
relief over this same period, the system comprising a filler and a hydrophilic
material, wherein oxymorphone is the sole active ingredient; and
(b) administering the dosage form to the subject, wherein the oxymorphone
Cmax is at least about 50% higher when the dosage form is administered to the subject
under fed versus fasted conditions.197
Upon appeal, the Federal Circuit agreed with the Board’s finding of obviousness.198
The
Maloney prior art reference expressly taught using controlled release solid dosage for-
mulations of oxymorphone, using both hydrophilic and hydrophobic materials, within
the dosage amount claimed, and enabled the claimed 12-hour release rate profile.199
The
teachings of Maloney were deficient in reciting the claimed “food effect” limitation, but
the Federal Circuit properly relied on the specification of the ’859 Application200
to con-
firm that the claimed “food effect” was an inherent property of oxymorphone itself,
present both in controlled release and immediate release formulations of the drug.201
The Federal Circuit concluded claim 8 was invalid as obvious over Maloney since the
reference provided sufficient motivation to arrive at the claimed controlled release oxy-
morphone formulation and the inherent “food effect” claim limitation added nothing of
patentable consequence.202
Practitioners at the time of the In re Kao decision predicted the end of second medi-
cal use patents in the United States if the In re Kao decision was not reversed upon ap-
197
U.S. Patent Application Serial No. 12/167,859 (filed Jul. 3, 2008) (hereinafter “the ’859 Application”)(disputed functional
language emphasized).
198
In re Kao at 1070-1071.
199
In re Kao at 1071.
200
In re Kao at 1070, citing In re Kubin, 561 F.3d 1353,1357 (“[e]ven if no prior art of record explicitly discusses the [limitation],
[applicant’s] application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the
[claimed invention], but rather a property necessarily present in [the claimed invention]”)
201
Id.
202
Id.

peal.203
While rehearing of In re Kao en banc was subsequently denied, second medical
use patents in the United States are still alive and well, at least by avoiding functional
inherent language. For example, the claims at issue in Kao may have been upheld as
patentable and non-obvious had the inventor’s “food effect” discovery been claimed us-
ing non-functional language.204
Par Pharmaceutical Par Pharmaceutical filed suit against TWi Pharmaceuticals alleg-
ing infringement of U.S. Patent 7,101,576205
covering Par’s FDA approved nanoparticu-
late megestrol acetate oral suspension, Megace® ES. TWi, in defense, asserted the claims
at issue were invalid as obvious. Claim 1 of the ’576 patent recites a method of treatment
using a nanoparticulate megestrol acetate suspension:
1. A method of increasing the body mass in a human patient suffering from
anorexia, cachexia, or loss of body mass, comprising administering to the
human patient a megestrol formulation, wherein:
(a) the megestrol acetate formulation is a dose of about 40 mg to about 800
mg in about a 5 mL dose of an oral suspension;
(b) the megestrol acetate formulation comprises megestrol particles having
an effective average particle size of less than about 2000 nm, and at least one
surface stabilizer associated with the surface of the megestrol particles; and
(c) the administration is once daily;
wherein after a single administration in a human subject of the formulation there is no
substantial difference in the Cmax of megestrol when the formulation is administered
to the subject in a fed versus a fasted state,
wherein fasted state is defined as the subject having no food within at least
the previous 10 hours, and wherein fed state is defined as the subject having
a high-calorie meal within approximately 30 minutes of dosing.206
TWi submitted substantial evidence supporting the District Court’s finding of obvious-
ness. In particular, TWi submitted a reference that specifically found that a 160 mg dose
of micronized megestrol acetate exhibited higher bioavailability than a 160 mg dose of
non-micronized megestrol acetate.207
A second submitted reference taught that reducing
particle size, either to nanoparticulate or microparticle size, could increase the bioavail-
ability of poorly soluble drugs.208
A third submitted reference taught the nanocrystalline technology used in the for-
mulation Megace® ES touted the potential to increase bioavailability, reduce fed-fasted
effects, allow higher dose loading with smaller dose volume, decrease time to therapeu-
tic levels, and reduce viscosity in poorly soluble drugs.209
Other references submitted
203
See, e.g., Daniel Feigelson, Inherently Incomprehensible: Does the CAFC’s View of Inherency in In Re Kao
Spell the End of Second Medical Use Patents in the USA?, America-Israel Patent Law Blog (Jul. 11, 2011,
1:24 PM), http://www.iliplaw.com/2011/07/inherently-incomprehensible-does-the-cafcs-view-of-inherency-in-in-re-kao-spell-the-end-of-
second-me.html.
204
Such as requiring administering the CR oxymorphone formulation to the subject in a fed state.
205
U.S. Patent No. 7,101,576 (filed Apr. 14, 2003)(hereinafter “the ’576 patent”).
206
Id. (disputed functional language emphasized).
207
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., CCB-11-2466, slip op. at 12.
208
Id.
209
Id. slip op. at 11.

by TWi supplied additional motivation in the art to arrive at the claimed invention, but
were silent with regard to the recited “food effect” limitation.
Regardless, the District Court, relying on TWi’s expert testimony that “an improve-
ment in bioavailability necessarily results in a reduction in any food effect, whether pre-
viously known or not”210
determined the claimed pharmacokinetic parameters inherent
properties of the obvious nanoparticulate formulation— citing In re Kao— which added
“nothing of patentable consequence.”211
The Federal Circuit found the District Court “erred in its inherency analysis under our
precedent.”212
In particular, the Federal Circuit reminded the District Court that while
“inherency may supply a missing claim limitation in an obviousness analysis...the con-
cept of inherency must be limited when applied to obviousness, and is present only when
the limitation at issue is the “natural result” of the combination of prior art elements....A
party must, therefore, meet a high standard in order to rely on inherency.”213
A claim lim-
itation which is described in the prior art or the patent specification as a “property that
is necessarily present” (as in Kao) meets this high standard.214
A claim limitation derived
from administering an obvious formulation, such as claiming the formulation’s serum
concentration, also meets this high standard, and cannot render that formulation non-
obvious.215
Citing Kao, the Federal Circuit reiterated that if a claimed limitation meets
this high standard, the claimed “inherent property” of the formulation simply “adds
nothing of patentable consequence.”216
In particular, the Federal Circuit found that the District Court’s analysis completely
ignored the metes and bounds of the functional claim limitation at issue: “[w]hile it may
be true that a reduction in particle size naturally results in some improvement in the
food effect, the district court failed to conclude that the reduction in particle size natu-
rally results in “no substantial difference” in the food effect...‘Inherency...may not be
established by probabilities or possibilities. There mere fact that a certain thing may re-
sult from a given set of circumstances is not sufficient.’”217
Since the Federal Circuit could
not conclude, based on the proffered evidence, that the food effect as claimed was neces-
sarily present in the prior art, the District Court’s judgment was vacated and remanded
for further analysis.218
2. Allergan v. Sandoz (2013)
In the early 1990’s Allergan began marketing a new single-agent anti-glaucoma med-
ication, Alphagan®, containing the alpha-2 agonist brimonidine.219
Unlike many anti-glaucoma medications, which are dosed once or twice daily, the FDA
only approved Alphagan® for dosing three times daily due to a low efficacy of twice-
a-day brimonidine.220
This recommended third dose, along with a high rate of ocular
210
Id. slip op. at 13.
211
Id.
212
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc.,773 F.3d 1186, 1194 (Fed. Cir. 2014).
213
Id. at 1194-1195.
214
Id. at 1195.
215
Id.
216
Id.
217
Id. at 1196, quoting In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981).
218
Id.
219
Allergan, Inc. v. Sandoz, Inc., 818 F.Supp.2d 974, 978 (E.D. Texas, 2011).
220
Id.

allergy to the drug, prompted Allergan to begin working on developing a better product
as soon as Alphagan® was approved.221
For patients whose glaucoma could not be ef-
fectively controlled with a single drug, the most common form of treatment at the time
was using a combination of two or more drugs, either serially - in separate formulations
- or fixed in the same formulation.222
Serial formulations were generally viewed as beneficial because the two or more
drugs are kept separate and stable and the dosing of each may be controlled or var-
ied depending upon the patient’s needs.223
Fixed formulations were generally viewed
as beneficial by ensuring patient compliance.224
Furthermore, at the time of this devel-
opment, the single agent medication Timoptic® containing the beta-blocker timolol (see,
e.g., Figure 5) was also on the market for the treatment of glaucoma.225

Figure 5
Allergan formulators began experimenting with certain fixed formulations of bri-
monidine with other anti-glaucoma medications, and discovered the combination of
0.2% brimonidine and 0.5% timolol improved the efficacy of brimonidine so much so
that the difference between twice-a-day brimonidine and three-times-a-day brimonidine
was minimized, and allowed for a twice-a-day brimonidine product with lowered ocular
allergy incidence. The twice-a-day combination formulation, later approved by the FDA,
was christened Combigan®.226
Allergan filed a patent application describing the combination formulation which
culminated into four issued patents, two of which are the subject of the inherency dis-
cussion.227
Claim 1 of U.S. Patent 7,323,463 encompasses the Combigan® formulation
composition of matter:
1. A composition comprising about 0.2% brimonidine by weight and about
0.5% timolol by weight as the sole active agents, in a single composition.228
Claim 4 of U.S. Patent 7,030,149 encompasses the corresponding method of use as fol-
lows:
221
Id. at 979.
222
Id at 981.
223
Id.
224
Id.
225
Id. at 982.
226
Id. at 998.
227
Allergan, Inc. v. Sandoz, Inc., 726 F.3d 1286, 1288 (Fed. Cir. 2013).
228
U.S. Patent No. 7,323,463 (filed Feb. 3, 2003)(hereinafter “the ’463 patent“).

4. A method of reducing the number of daily topical ophthalmic doses of
brimondine administered topically to an eye of a person in need thereof for
the treatment of glaucoma or ocular hypertension from 3 to 2 times a day with-
out loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight,
said method comprising administering said 0.2% brimonidine by weight and
0.5% timolol by weight in a single composition.229
Sandoz Inc., Alcon Laboratories, Inc., Falcon Pharmaceuticals, Ltd., Apotex, Inc., Apotex
Corp., and Watson Laboratories, Inc. (collectively “Sandoz”) each sought approval to
market a generic version of Combigan®, filed an ANDA asserting the claims of the ’463
patent and the ’149 patent invalid as anticipated and obvious, and Allergan promptly
filed suit against each party alleging infringement.230
In a consolidated action at the
district court level the claims at issue were found valid and non-obvious, and Sandoz
timely appealed to the Federal Circuit.231
Sandoz’s obviousness argument was based upon the teachings of a prior U.S. patent,
the DeSantis reference, describing fixed combinations of alpha-2 agonists and beta-blockers
for the treatment of glaucoma.232
DeSantis explained a significant number of patients
require more than one drug to achieve efficacy in treating glaucoma, and that serial ad-
ministration often resulted in poor patient compliance.233
As a solution to this problem,
DeSantis proposed fixed formulations containing the beta-blocker timolol, preferably in
a concentration of 0.01 to 3.0% by weight (meeting the 0.5% claim limitation), with an
alpha-2 agonist, preferably 0.2 to 2.0% by weight (meeting the 0.2% claim limitation).234
While DeSantis did not expressly teach brimonidine, DeSantis incorporated by refer-
ence certain alpha-2 agonists described in a literature publication, which disclosed bri-
monidine.235
Sandoz submitted an additional publication describing serial administra-
tion of 0.2% brimonidine with 0.5% timolol, and submitted additional evidence demon-
strating it was common at the time of invention to dose brimonidine and timolol serially
twice per day rather than three times per day for the treatment of glaucoma.236
The District Court found each of the claims at issue not obvious, and deemed the mo-
tivation within the DeSantis reference, espousing fixed formulations to increase patient
compliance, insufficient and “did not motivate a person of skill in the art to develop fixed
combinations with a reasonable expectation of success, because the FDA did not consider
improving patient compliance as a factor in its approval decision.”237
While agreeing that
FDA approval may be relevant to the obvious analysis, the Federal Circuit found clear
error in the District Court’s conclusion, stating “[t]here is no requirement in patent law
that the person of ordinary skill be motivated to develop the claimed invention based on
a rationale that forms the basis for FDA approval. Motivation to combine may be found
in many different places and forms; it cannot be limited to those reasons the FDA sees
fit to consider in approving drug applications.”238
The Federal Circuit thus concluded
229
U.S. Patent No. 7,030,149 (filed Apr. 19, 2002)(hereinafter “the ’149 patent”)(disputed functional language emphasized).
230
Allergan, Inc. v. Sandoz, Inc., 818 F.Supp.2d 974, 987 (E.D. Texas, 2011).
231
Allergan, Inc. v. Sandoz, Inc., 726 F.3d 1286, 1288 (Fed. Cir. 2013).
232
Id. at 1289-1290.
233
Id.
234
Id. at 1290.
235
Id.
236
Id.
237
Id. at 1291.
238
Id.

that the evidence submitted established sufficient motivation to combine brimonidine
and timolol in a fixed combination product, and there was a reasonable expectation of
success, as suggested by DeSantis, in so doing.239
Moreover, in light of the extensive body of evidence submitted by Sandoz, the Fed-
eral Circuit held Allergan’s unexpected results demonstrating an increased efficacy of
brimonidine when combined with timolol and decreased ocular allergy incidence did
not tip the balance in favor of a finding of nonobviousness, at least for the fixed formu-
lation of claim 1.240
The Federal Circuit thus held claim 1 of ’463 patent, encompass-
ing the Combigan® formulation, unpatentable as obvious.241
The Federal Circuit held,
however, method claim 4 of the ’149 patent, reciting the functional language “adminis-
tered...without loss of efficacy”, not obvious.242
Judge Dyk, in dissent, railed against the majority’s decision— that method claim 4
was not obvious while composition claim 1 was— as wrongly decided.243
Judge Dyk
agreed with the majority that the composition claim 1 was obvious even though it had
the unexpected property of being dosed twice a day without loss of efficacy, but would
have drawn the same conclusion with regard to claim 4 using similar reasoning, citing
Cruciferous Sprout:
[w]hile a new and nonobvious method of using an existing (or obvious)
composition may itself be patentable . . . a newly-discovered result or prop-
erty of an existing (or obvious) method of use is not patentable. In this case,
the method of claim 4 consists of a single step: applying a fixed combination
of 0.2% brimonidine and 0.5% timolol twice a day. This method was surely
obvious to try. The majority recognizes that “it was common at the time of the
invention to dose the serial application of brimonidine and timolol twice per
day,” and that “the prior art shows concomitant administration of brimoni-
dine and timolol . . . dosed twice per day.” Moreover, the record shows that
reducing the number of daily doses of anti-glaucoma drugs was seen as valu-
able for improving patient compliance and for reducing exposure to toxic in-
gredients. The method of applying a fixed combination of 0.2% brimonidine
and 0.5% timolol twice a day would therefore have been obvious over the
prior art. The majority’s outcome appears to rest, therefore, on the notion that
claim 4 was not obvious because it claims the result of twice-a-day dosing—
avoiding “a loss of efficacy in the afternoon.” Avoiding a “loss of efficacy” is
not a separate step, but rather a result of the claimed method. We should rec-
ognize in this case, as we did [previously], that “[n]ewly discovered results
of known processes directed to the same purpose are not patentable.”244
The majority agreed with Judge Dyk that the inherency doctrine may apply to an oth-
erwise obvious claim, but rationalized that use of inherency to render this functional
language moot was inappropriate since there was no additional evidence of record (un-
like Kao), either in the prior art or in the’149 patent specification, establishing the dose
239
Id. at 1292.
240
Id. at 1293.
241
Id. at 1295.
242
Id.
243
Id. at 1295-1296.
244
Id.

reduction “without loss of efficacy” was an inherent property always and necessarily
resulting when combining 0.2% brimonidine and 0.5% timolol.245
C. Inherent Obviousness Deconstructed
Invalidation of a claim as anticipated is different from invalidation of that same claim as
obvious. Anticipation requires a single prior art reference disclosing the claimed inven-
tion either expressly or inherently, and is fairly black and white— the claimed invention
is disclosed in that single reference or it is not.246
Establishing a prima facie case of obvi-
ousness, in contrast, may require a combination of two or more references to demonstrate
“that a skilled artisan would have reason to combine the teaching of the prior art refer-
ences to achieve the claimed invention, and that the skilled artisan would have had a rea-
sonable expectation of success from doing so.”247
Despite certain incredulity expressed
within the patent community,248
in the context of obviousness, once this motivation has
been established, the doctrine of inherent anticipation is then applicable.
The following decision tree, proposed in view of Dillon, Kao, Par Pharmaceutical, and
Allergan, depicts how inherent anticipation can fit within the obviousness inquiry.

For example, if a functional property has been claimed, the first question to ask is
whether there is a motivation to arrive at the claimed invention, absent the functional
property. If the answer to that question is yes, a prima facie case of obviousness has been
established, and inherency may then be applied. If that claimed functional property is
also an inherent feature of the invention (as in Kao), the functional property is given no
patentable weight. If the claimed functional property is not an inherent feature, or if it is
245
Id. at 1294, note 1 (“Of course, it may be true that the mere administration of 0.2% brimonidine and 0.5% timolol twice
daily in any fixed combination formulation inherently produces the claimed result. Alternatively, it may also be true that only
certain fixed-combination formulations produce this result. On the present record, we cannot draw a conclusion in favor of
either proposition”).
246
ed., Mar. 2014) § 2131.
247
In re Cyclobenzaprine, 676 F.3d at 1068-69.
248
See, e.g., Dittmann, supra note 11.

not possible to determine whether the claimed functional property is an inherent feature
(as in Par and Allergan), inherency is not applicable.
Furthermore, if no functional property has been claimed, as in Dillon’s composition,
the first question to ask, as above, is whether there is a motivation to arrive at the claimed
invention. If the answer to that question is yes, a prima facie case of obviousness has been
established, and inherency may then be applied, albeit in the form of rebuttal evidence.
Conclusion
Inherency has been characterized in dissent as presently “unbounded” and which “threat-
ens to stymie innovation by withdrawing from the realm of patentability that which has
not before been known, used, or benefitted from.”249
While such language might be
viewed as overly-dramatic, the results of Schering, Dillon, and their successors have cer-
tainly made the life of the patent applicant more difficult: once an Examiner rejects a
claim or claim limitation as inherent over a reference, and the Examiner presents suf-
ficient reasoning showing this inherency, the burden shifts to the patent applicant to
demonstrate the lack thereof or an unobvious, patentable, difference.250
Post-Schering, the patent applicant cannot argue that the claims are novel and non-
obvious because none prior to the date of invention knew, recognized, or appreciated
the claimed subject matter. Of course, thoughtful claim drafting may allow a patent
applicant to avoid a potential inherency challenge in order to obtain an issued patent.
Conversely, however, in the context of invalidating an issued patent, as blogger-
practitioner-professor Dennis Crouch of Patently-O puts it: “Proving Anticipation-by-
Inherency: It is Hard.”251
The litigant attempting to invalidate a patent claim using the
inherency doctrine must establish the claimed subject matter is necessarily, always, and
inevitably present under a high burden of proof— by clear and convincing evidence. A
claimed invention may thus experience both negatives, such as where the doctrine poses
a significant hurdle to overcome during patent prosecution; and positives, such as where
the doctrine poses a shield to invalidation when asserting rights under an issued patent,
of this “unbounded” doctrine.
The enactment of the American Invents Act (AIA)252
marked the most dramatic change
in United States patent law since the 1952 Patent Act. With its enactment, and in an effort
to harmonize U.S. patent law with the rest of the world, the United States moved from a
first-to-invent patent system to a first-to-file patent system on March 16, 2013.253
Newly
codified 35 U.S.C. § 102(a)(1) (AIA)254
includes language remarkably similar to Article
249
In re Montgomery, 677 F.3d 1375, 1383-1384 (Fed. Cir. 2012) (Lourie, J., dissenting).
250
ed., Mar. 2014) § 2112.
251
Dennis Crouch, Proving Anticipation-by-Inherency: It is Hard, Patently-O (Dec. 16, 2013),
http://patentlyo.com/patent/2013/12/proving-anticipation-by-inherency-its-hard.html.
252
Leahy-Smith America Invents Act, Pub. L. Bi, 112-29, 125 Stat. 284 (2011).
253
Applications filed prior to March 15, 2013 are examined under the old law, and, with some exceptions, applications claim-
ing priority to or benefit from a date after March 15, 2013 are examined under the new law.
254
35 U.S.C. § 102(a)(1) (AIA): (a) NOVELTY; PRIOR ART. A person shall be entitled to a patent unless –
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available
to the public before the effective filing date of the claimed invention. EPC Art. 54(1)(2): (1) An invention shall be considered
to be new if it does not form part of the state of the art.

54 of the European Patent Convention (EPC)255
— prior art is that which is “otherwise
available to the public.” Practitioners Bjorkman, Voortmans and Block warn, however,
that this linguistic similarity is deceptive since “otherwise available to the public” will
be interpreted very differently depending upon the jurisdiction.256
For example, EPC decisions have consistently rejected the doctrine of inherency, and
have specifically found “available to the public” incompatible with inherency.257
In con-
trast, AIA legislative history indicates “otherwise available to the public” is intended to
include inherent disclosures found within the prior art.258
Thus, following and under-
standing the nuances of the doctrine of inherent anticipation as it evolves within the U.S.
court system, within the context of novelty as well as obviousness, remains essential to
patent practitioners and litigators working within the confines of the new AIA regime.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral
description, by use, or in any other way, before the date of the European patent application.
255
EPC Art. 54(1)(2): (1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral
description, by use, or in any other way, before the date of the European patent application.
256
Dale Bjorkman, Gilbert Voortmans & Lindsay M. Block, “‘Made Available to the Public’ - Understanding the Differences of the
America Invents Act from the European Patent Convention in Its Definition of Prior Art.” 4 Cybaris Int. Pr. Rev. 191, 193 (2013).
257
Id. at 215-217.
258
Id. at 216, 217 (quoting Senator Kyl: “Another important aspect of public availability or accessibility is the doctrine of
inherency . . . This doctrine applies to products sold to the public as well as published references. Thus, once a product is sold
on the market, any invention that is inherit to the product becomes publicly available prior art and cannot be patented”. 157
Cong. Rec. S1360, at 1370 (daily ed. Mar. 8, 2011)).

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